-Do these researchers have IRB approval yet? If not, why are they soliciting patients?

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This was a key problem with the Miller study. If you read some of my earlier posts you'll see that that first post regarding the study was done with the understanding that IRB approval had been received. Dr. Miller quickly informed us that was incorrect and the post was immediately pulled from the PR Forums and, in retrospect, it should have been pulled from the MECFS Forums. I think the thought was well, its out there now -sobeit..Dr. Miller thought it was best that it not be out there but it was This was a mistake - but it was nothing more than a mistake. There was no hidden agenda - it was us and Dr. Miller making a mistake and it had nothing to do with his honest attempt to find XMRV. If that was the problem - patients protesting that Dr. Miller did not have IRB approval yet - I think we would have gotten over it!

Dr. Yes - It is nearly impossible to understand how a study coordinator or principal investigator in this situation could be so misinfomed or mistaken about who his collaborators are. It is not as simple as being wrong about a yes/no; in order to have established a collaboration there would have to have been communications and discussion between his associates and the WPI, of which he surely would have been aware.

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I agree - this is another weird situation that we have gotten stuck in the middle of. Why should anyone doubt the word of a researcher when asked a simple question like this? That should be enough to go on but apparently its not. It doesn't bode well for patient researcher communication and trust. Its weird.

-A lot of people have tested XMRV positive and we don't know if they all have the same illness. In order to be sure, assuming this is actually a study on CFS patients and not merely on XMRV detection itself, they will have to have some selection criteria to specify CFS patients...what criteria will be used?

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That's a question - although I don't think it's the central question any more..The central question in my opinion has changed from finding how much XMRV is in CFS demonstrate that he can find XMRV and show other labs how he found it; eg. the most important thing now is to validate the WPI's ability to find XMRV. If he can find it in fibromyalgia or Lyme Disease or multiple sclerosis or any of the other groups the WPI has found it in - then that's fine.

The key factor for me is his validation that the patients actually did have a positive diagnosis from the WPI; that was one thing we were struggling with in the Miller study - how to prove that they had that diagnosis. After that, the disease group they fit into, at least in my opinion, is not important. When last I heard I believe we were going to allow CFS and FM patients into the study.

So long as he is clear in his paper which group of patients he looked at - did they have FM or CFS or whatever - then I don't see any reason to oppose his study. The only reasons I can see to oppose if he is using a methodology that will not find XMRV.

If you were referring to me, when you mentioned hurling obscenities, then i have to say that in this case i mean it this way.

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I'm sorry for the misunderstanding, Eric. I was not saying that you have hurled obscenities or promoted conspiracy theories. To my knowledge, you have not done so. I apologize if the way my post was written made it seem like I was accusing you of that behavior.

So i would like to ask you this:
If it is true that Dr. Maldarelli has said that the Mikovits lab and potentially other labs like Lo's and Ruscetti's are involved, even though this is not the case, what is your opinion regarding such a behaviour?
How would you explain it and what would you do about it? What would you advise ME/CFS patients to do?

I would also like to know in what way the CFIDS Association is involved with the Maldarelli study. Will it change your involvement/endorsement (if there is), if indeed Dr. Maldarelli was not telling the truth?

I am sorry i have to ask those questions.

Eric

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The CFIDS Association is not involved in Malderelli's study, neither funding it nor providing BioBank samples. We shared the information about Malderelli's study because we knew it would be of interest to patients. I do not, at this point, have information on the status of IRB approval, etc etc etc. I will try to get answers this week.

To Angela's point, it is not an urban myth that researchers believed CFS was the kiss of death to their careers. My recollection of Osler's Web is that Hilary Johnson cited such examples. Members of the CFSAC have stated this as well. It is a problem we've been confronted with for a long time. In the last 2 or 3 years, this trend has started to turn around. I, for one, do not want to go back.

- Dr. Yes - Dr. Maldarelli reportedly told one of the members at ME/CFS forums that they want to test patients who've previously been tested for XMRV in order to get the 'sickest of the sick' in their cohort. However, they require that participants travel to Bethesda, Maryland to contribute their samples. Unless they live locally, few if any of the 'sickest of the sick' can travel that far or at all, period. Even most of the moderately sick probably wouldn't be able to make the trip.

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This was another thing we struggled with. We had definite financial limits. Our solution was going to be to open up the study to people in a broad area and then try to get most of the samples from the Seattle area. Its very expensive to have phlebotomists gather samples. Its quite expensive, actually, just to have patients go to an out clinic and have them collect the blood and then ship it.. Since the trial was partially patient funded we definitely did not have the means to do much of that. We were going to try to assess functionality and then get as severely afflicted as possible patients in the Seattle area to give blood. If we had to go outside the area we would and we had people willing to fly to Seattle to give blood.

Its possible that Dr. Malderilli is bumping against some of the same issues. But a larger issue is whether it's necessary to have only the most severely ill patients get tested in order to support the study....Let's say it is harder to find XMRV in less patients - that doesn't mean it's impossible to find it - it simply means that you'll have a lower positive rate. You should still be able to find virus. If you have a mix of more severely ill and less severerly patients - 100% of whom tested positive for it by the WPI - Dr. Malderilli should still be able find it in a percentage of them and even the validation of 20% of the WPI tested patients would be aHUGE breakthrough when many studies find zero. VIP Dx after all reported they have 50% positive rates from all sorts of patients.

Dr. Malderilli;s inability to only look for XMRV in severely, severely ill patients is not a reason, in my book, to not support his study. He has still loaded the deck, so to speak, by looking at patients who already tested positive....and while I would be surprised if he could validate all the patients - since the WPI is obviously the most adept at find XMRV - he should be able, using the same techniques the WPI did, to find it in some of them - and that is what the field needs at this point.

What MIGHT scare them away is the stranglehold of the proponents of psychogenic explanations, lack of funding from the funding institutions, and constant negative and contamination studies being spun as if they are 'scientific truth' leading other scientists to be intimidated into following the nebulous status of 'science by consensus'.

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I agree this is a tricky situation. Given the labeling of CFS over the years - researchers are more likely to drop back into the default conversation for CFS than to take on a new one. It takes much more to push them into the 'valid physiological illness' viewpoint that it does to have them drift back into the 'messy psychogenic illness that we don't want to deal with' viewpoint. That is always out there waiting to swallow up as much of ME/CFS as it can.

I don't have a problem so, to speak with the contamination studies - those were ALWAYS going to be done as researchers delved more deeply into XMRV. The fact that two labs found something that they first thought was XMRV and later turned out not to be - was simply what happened. I don't think they fixed their results. I think Huber would have LOVED to find XMRV - she was already studying endogenous retroviruses in CFS and she jumped right onto XMRV as soon as it happened. It just so happened that the results turned out different that she (I'm sure) and we hoped. Why would she not want to validate a finding in her field of interest? Of course she wanted to validate it...

The problem, for me, with the contamination studies was the drift that occurred in the media,....the quick return, particularly in the UK - back to the 'default conversation' - viruses do not play a role in CFS.

I would note, though, that Dr. Coffin did not, despite being part of two of those studies - partake in that drift. Neither ultimately did Dr. Racaniello or Dr. Rein... They all boxed those studies where they should have been boxed - as a warning to XMRV researchers - and nothing more. All the major studies continued as well. To me that suggests that many of the researchers that we know about integrated the Retrovirology findings correctly - they saw them as warnings - and moved on. Some - McClure and Stoye - have staked out their positions - others appear to be more in the middle ground.

This is such a crazy field.....you have one set of researchers stating that the IAP test is so much more sensitive that the mtDNA test and you have another set of researchers asserting that the mtDNA test is more sensitive.....And we are stuck in the middle - appalled at the sloppiness and inexactness of all of this.

I think there's hope too. The Workshop in the US is clearly going to be focused on pathophysiology. We're going to see pathophysiologists digging into CFS in a federally produced Workshop....That is where the US is looking....which is good news.

The CFIDS Association is not involved in Malderelli's study, neither funding it nor providing BioBank samples. We shared the information about Malderelli's study because we knew it would be of interest to patients. I do not, at this point, have information on the status of IRB approval, etc etc etc. I will try to get answers this week.

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I can not understand how the CAA promoted this study to the extent of sending letters to all SolveCFS BioBank participants without having basic knowledge such as whether it had received IRB approval yet, what the study design was, who funded it, how it relates to the BLood Working Group Phase III, assays to be used, confirmed partners................. I can understand an error of this magnitude, perhaps, with an internet post - someone being hasty and careless, but the process of sending out letters takes time and the involvement of a number of people.

I look forward to the CAA's answers next week.

I am proud of the patient community's response to the Dr Miller and Dr Maldarelli's studies. We deserve and demand quality research, properly implemented, and are being forced to become educated about what that is, and how to ensure we get it.

Gone are the paternalistic days where a researcher or organization can say, "trust me, this is good for you, now do what you're told."

Well designed studies such as WPI's, Dr Singh's, Dr Hanson's...... have no problems with patient reaction or participation. Hopefully we have educated Dr Miller and Dr Maldarelli as to the quality of research we expect.

I believe, that if both of these studies had been presented to the patient population with good design, and IRB approval, few of these problems would have arisen. I can understand the CAA wanting to share info about an upcoming study. Hopefully, it will never be done again in a manner that jeopardizes the study.

To Angela's point, it is not an urban myth that researchers believed CFS was the kiss of death to their careers. My recollection of Osler's Web is that Hilary Johnson cited such examples. Members of the CFSAC have stated this as well. It is a problem we've been confronted with for a long time. In the last 2 or 3 years, this trend has started to turn around. I, for one, do not want to go back.

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Can you cite those examples? What context were those allegations made, and by whom? They may still be (indeed likely are) a myth- urban or otherwise, depending on who was claiming them. It is a common claim, but not rooted in reality or reliable evidence, as I've shown.

But even if some researchers believed that- it is the assumption that the PATIENTS are causing that which is clearly wrong, and is how you were using the claim, Jennie.

I can not understand how the CAA promoted this study to the extent of sending letters to all SolveCFS BioBank participants without having basic knowledge such as whether it had received IRB approval yet, what the study design was, who funded it, how it relates to the BLood Working Group Phase III, assays to be used, confirmed partners................. I can understand an error of this magnitude, perhaps, with an internet post - someone being hasty and careless, but the process of sending out letters takes time and the involvement of a number of people.

I look forward to the CAA's answers next week.

I am proud of the patient community's response to the Dr Miller and Dr Maldarelli's studies. We deserve and demand quality research, properly implemented, and are being forced to become educated about what that is, and how to ensure we get it.

Gone are the paternalistic days where a researcher or organization can say, "trust me, this is good for you, now do what you're told."

Well designed studies such as WPI's, Dr Singh's, Dr Hanson's...... have no problems with patient reaction or participation. Hopefully we have educated Dr Miller and Dr Maldarelli as to the quality of research we expect.

I believe, that if both of these studies had been presented to the patient population with good design, and IRB approval, few of these problems would have arisen. I can understand the CAA wanting to share info about an upcoming study. Hopefully, it will never be done again in a manner that jeopardizes the study.

I think this is overly generous. Racaniello was extremely sloppy and joined the UK bandwagon in stating that it was pretty much the end of XMRV. Only after getting caught with his pants down did he retract his comments but the damage was already done.

On the one hand I do have some respect that he retracted his comments but on the other his credibility took a huge hit for not doing proper due diligence in the first place. And part of me wonders whether he only retracted because he realized that statement could come back to haunt him. After all, this was a written comment to one of the largest global media outlets, not some off the cuff remark made at a cocktail party.

I think this is overly generous. Racaniello was extremely sloppy and joined the UK bandwagon in stating that it was pretty much the end of XMRV. Only after getting caught with his pants down did he retract his comments but the damage was already done.

On the one hand I do have some respect that he retracted his comments but on the other his credibility took a huge hit for not doing proper due diligence in the first place. And part of me wonders whether he only retracted because he realized that statement could come back to haunt him. After all, this was a written comment to one of the largest global media outlets, not some off the cuff remark made at a cocktail party.

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Floyd is right, especially about the damage already being done by his remark. The retraction did not get the same attention.

I think this is overly generous. Racaniello was extremely sloppy and joined the UK bandwagon in stating that it was pretty much the end of XMRV. Only after getting caught with his pants down did he retract his comments but the damage was already done.

On the one hand I do have some respect that he retracted his comments but on the other his credibility took a huge hit for not doing proper due diligence in the first place. And part of me wonders whether he only retracted because he realized that statement could come back to haunt him. After all, this was a written comment to one of the largest global media outlets, not some off the cuff remark made at a cocktail party.

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I think absolutely he retracted it because he was worried it could come back to haunt him. He thought it was valid and after doing some more research he realized he might be wrong! So he retracted it as quickly as he could. No scientist wants to publically shown to be wrong....

I agree that his initial statement contributed to the 'drift'...and it was quite unfortunate....

I do imagine he will be more careful in the future with XMRV since it did not go well for him

Can you cite those examples? What context were those allegations made, and by whom? They may still be (indeed likely are) a myth- urban or otherwise, depending on who was claiming them. It is a common claim, but not rooted in reality or reliable evidence, as I've shown.

But even if some researchers believed that- it is the assumption that the PATIENTS are causing that which is clearly wrong, and is how you were using the claim, Jennie.

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You can check out Dr Glazer's comments at the last CFSAC meeting where he said that for 20 years he never tried to get a grant through the NIH because he knew it wouldn't happen. (Then he tried and failed!...and then finally got it by going to another review panel).

If you just look at the new grant funding approval rates - 8%, or the amount of money spent on CFS at the NIH ($4 million), or where the program is located (ORWH) or the fact that the ORWH isn't given ANY money for its CFS program (except 1/2 staff person).... or the fact that it was reported that the CFS job at the CDC got 2 applicants (not sure if that's true)....it's pretty clear that that CFS researchers have alot stacked up against them. It wasn't until the last CFS SEP panel that we were able to get CFS researchers on there (amazing)..Unfortunately they received few applications.

The grant application rate tells it all - its VERY low....hopefully with the new CFS SEP panel researchers will get the idea they have a chance now and they will rise......

You can check out Dr Glazer's comments at the last CFSAC meeting where he said that for 20 years he never tried to get a grant through the NIH because he knew it wouldn't happen. (Then he tried and failed!...and then finally got it by going to another review panel).

If you just look at the new grant funding approval rates - 8%, or the amount of money spent on CFS at the NIH ($4 million), or where the program is located (ORWH) or the fact that the ORWH isn't given ANY money for its CFS program (except 1/2 staff person).... or the fact that it was reported that the CFS job at the CDC got 2 applicants (not sure if that's true)....it's pretty clear that that CFS researchers have alot stacked up against them. It wasn't until the last CFS SEP panel that we were able to get CFS researchers on there (amazing)..Unfortunately they received few applications.

The grant application rate tells it all - its VERY low....hopefully with the new CFS SEP panel researchers will get the idea they have a chance now and they will rise......

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But 'research' studies claiming psychogenic explanations for CFS are extremely well-funded and career enhancing. So there is something else going on that is NOT to do with recalcitrant patients.

I can not understand how the CAA promoted this study to the extent of sending letters to all SolveCFS BioBank participants without having basic knowledge such as whether it had received IRB approval yet, what the study design was, who funded it, how it relates to the BLood Working Group Phase III, assays to be used, confirmed partners................. I can understand an error of this magnitude, perhaps, with an internet post - someone being hasty and careless, but the process of sending out letters takes time and the involvement of a number of people.

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I said that I did not have the information. I did not say that the Association did not have the information. Furthermore, the Association's notice clearly states that "Participation in this study will not be coordinated through the SolveCFS BioBank and any questions about it should be directed to the NIH." and provided Dr. Malderelli's contact info to do so. Anyone that has questions about the study, including questions about cohort selection, collaborators and study design, should contact Dr. Malderelli as he is the person responsible for it.

The Association occasionally publicizes information about research studies being conducted by other parties, and we do this because we know patients are interested. If there is additional information that I can provide, I will do so, but the responsibility for study design and fielding detailed inquiries lies with Dr. Malderelli.

I can not understand how the CAA promoted this study to the extent of sending letters to all SolveCFS BioBank participants without having basic knowledge such as whether it had received IRB approval yet, what the study design was, who funded it, how it relates to the BLood Working Group Phase III, assays to be used, confirmed partners................. I can understand an error of this magnitude, perhaps, with an internet post - someone being hasty and careless, but the process of sending out letters takes time and the involvement of a number of people.

I am proud of the patient community's response to the Dr Miller and Dr Maldarelli's studies. We deserve and demand quality research, properly implemented, and are being forced to become educated about what that is, and how to ensure we get it.

Thanks Dr. Yes for all the information
[...]
I agree - this is another weird situation that we have gotten stuck in the middle of. Why should anyone doubt the word of a researcher when asked a simple question like this? That should be enough to go on but apparently its not. It doesn't bode well for patient researcher communication and trust. Its weird.

That's a question - although I don't think it's the central question any more..The central question in my opinion has changed from finding how much XMRV is in CFS demonstrate that he can find XMRV and show other labs how he found it; eg. the most important thing now is to validate the WPI's ability to find XMRV. If he can find it in fibromyalgia or Lyme Disease or multiple sclerosis or any of the other groups the WPI has found it in - then that's fine.

The key factor for me is his validation that the patients actually did have a positive diagnosis from the WPI; that was one thing we were struggling with in the Miller study - how to prove that they had that diagnosis. After that, the disease group they fit into, at least in my opinion, is not important. When last I heard I believe we were going to allow CFS and FM patients into the study.

So long as he is clear in his paper which group of patients he looked at - did they have FM or CFS or whatever - then I don't see any reason to oppose his study. The only reasons I can see to oppose if he is using a methodology that will not find XMRV.

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In the text about the study it says

To be eligible for the study, you must have a diagnosis of CFS and must be under the care of a physician.

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, so they clearly only want to look at CFS patients. The only question is CFS diagnosed by whom and using which criteria.

I'm sorry for the misunderstanding, Eric. I was not saying that you have hurled obscenities or promoted conspiracy theories. To my knowledge, you have not done so. I apologize if the way my post was written made it seem like I was accusing you of that behavior.

The CFIDS Association is not involved in Malderelli's study, neither funding it nor providing BioBank samples. We shared the information about Malderelli's study because we knew it would be of interest to patients. I do not, at this point, have information on the status of IRB approval, etc etc etc. I will try to get answers this week.

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Thanks, Jennie. No problem. I had used some not so nice words, so i thought you might have meant me.

Thanks for trying to get the answers. I think in general it's a good idea for the CFIDS Association to share information about studies, but maybe it would be good to do some more checks about the methods used etc. As there do seem to be valid concerns about the IAP test, for example.

Independently of the CAA being involved or not, i think the discrepancy between what Dr. Maldarelli reportedly has said and what the WPI has said, raises some questions that have to be answered.
I think this is a case where it is necessary to find out the truth and get to the bottom of things. Because it was said by someone at the NCI and i think it is crucial for us what is going on inside these institutions and we are not talking about a minor detail here (the participation of a lab, and not any lab, the WPI).
So i hope that the CAA, as the largest and most influential organisation of it's kind, which sees itself as being the main voice of people with ME/CFS in the USA (i guess so, and rightfully so, if it is doing a good job) will work towards finding out what has happened and why. And then take a position, whatever the appropriate position will be.

....and while I would be surprised if he could validate all the patients - since the WPI is obviously the most adept at find XMRV - he should be able, using the same techniques the WPI did, to find it in some of them - and that is what the field needs at this point.

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I'm behind on this thread, but this is yet another example of subtly distorting the facts. You casually slip the phrase "using the same techniques the WPI did" in there, when there is absolutely no indication that his study would use the WPI's methods.

The WPI started off using nested PCR - no culturing...and they were able to find it using VP62 (Look at the back of the supplemental section)....It didn't seem that hard at the beginning...It's just turned out to be more difficult than anyone expected.

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Can you please provide a link (and quote) that supports this claim? I've looked through all the Science materials and saw nothing to indicate this, but perhaps I overlooked it.

Can you cite those examples? What context were those allegations made, and by whom? They may still be (indeed likely are) a myth- urban or otherwise, depending on who was claiming them. It is a common claim, but not rooted in reality or reliable evidence, as I've shown.

But even if some researchers believed that- it is the assumption that the PATIENTS are causing that which is clearly wrong, and is how you were using the claim, Jennie.

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Very well said, Angela. I can't speak for CFSAC, but I did read Osler's Web very recently. You are absolutely correct, as you state elsewhere, that many interested researchers turned away out of frustration with and disgust towards the institutional bias against funding physiological research. I don't recall a single instance of a researcher losing interest because of "uppity" patients (unless you count the likes of Stephen Straus, who was at the heart of the bias to begin with, and who used lines of reasoning remarkably reminiscent of this "blame the patient" attitude in order to support his "theories").

I also remember the good 'ol days when Myra McClure had given up on CFS research because of the unruly patients. Of course, that was also a couple published papers ago...